沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.072895632905462892552892742884132894100.27
228.182900522897962899240.07
单位质量响应值RSD%判断
10310.3010288.290.16数据可信
供试品溶液-2024032721批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127185-271854.6089.5839.124.619.5839.12
252669-526698.9298.93
344412-444127.5297.53
474678-7467812.65912.66
550964-509648.6398.64
689068-8906815.09915.10
10min1101714-10171417.24326.2522.6517.2526.2722.66
2159294-15929427.00427.02
3134923-13492322.87222.88
4164975-16497527.96727.99
5160732-16073227.24727.26
6207489-20748935.17435.20
15min1232642-23264239.43840.4412.6439.4740.5012.65
2253529-25352942.97943.04
3198379-19837933.62933.68
4230365-23036539.05239.12
5227955-22795538.64338.70
6288455-28845548.89948.98
20min1305133-30513351.72648.3411.5751.8348.4711.56
2311682-31168252.83752.97
3237507-23750740.26240.37
4271068-27106845.95246.08
5263300-26330044.63544.76
6322393-32239354.65254.82
30min1329667-32966755.88651.949.7456.0752.149.73
2330148-33014855.96756.19
3256687-25668743.51443.69
4308602-30860252.31552.52
5285780-28578048.44648.64
6327356-32735655.49455.75
45min1329178-32917855.80352.009.4356.0852.309.43
2330017-33001755.94556.26
3259016-25901643.90944.16
4310123-31012352.57252.87
5285534-28553448.40448.68
6326683-32668355.38055.73
60min1329622-32962255.87851.999.3056.2552.379.30
2328806-32880655.74056.15
3259217-25921743.94344.26
4309622-30962252.48752.87
5286641-28664148.59248.95
6326250-32625055.30655.75
极限1330740-33074056.06754.402.9956.5454.863.03
2329290-32929055.82256.32
3307191-30719152.07552.47
4319166-31916654.10554.58
5312542-31254252.98253.42
6326367-32636755.32655.86
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.072898122908102909142900762903502903920.17
228.182899592904532902060.13
单位质量响应值RSD%判断
10345.2810298.300.33数据可信
供试品溶液-2024032721批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153779-537799.0978.8834.899.108.8834.88
273221-7322112.38612.39
328376-283764.8004.80
448691-486918.2368.24
537694-376946.3766.38
673234-7323412.38812.39
10min1155202-15520226.25328.8914.9126.2728.9014.92
2198232-19823233.53133.55
3138399-13839923.41123.42
4153353-15335325.94025.95
5180409-18040930.51730.53
6199048-19904833.66933.69
15min1232387-23238739.30943.049.9539.3743.109.95
2284669-28466948.15248.23
3249414-24941442.18942.24
4225778-22577838.19138.25
5249411-24941142.18842.25
6284889-28488948.19048.27
20min1276354-27635446.74649.988.1546.8750.128.15
2324723-32472354.92855.08
3304309-30430951.47551.59
4267931-26793145.32145.44
5279861-27986147.33947.47
6319832-31983254.10054.26
30min1306879-30687951.90953.225.4352.1153.445.44
2330977-33097755.98656.23
3331549-33154956.08256.29
4296213-29621350.10550.30
5295608-29560850.00350.21
6326626-32662655.25055.50
45min1311199-31119952.64053.574.5952.9353.874.60
2332067-33206756.17056.51
3328467-32846755.56155.86
4301773-30177351.04651.33
5299062-29906250.58750.88
6327440-32744055.38755.73
60min1313599-31359953.04653.574.5653.4253.974.58
2330767-33076755.95056.39
3329020-32902055.65456.04
4300496-30049650.83051.19
5299147-29914750.60150.98
6327323-32732355.36755.80
极限1315983-31598353.44954.702.4453.9155.192.47
2331098-33109856.00656.53
3329568-32956855.74756.23
4322515-32251554.55455.00
5312178-31217852.80653.27
6329027-32902755.65656.18
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.072903862901162898602897172898912899940.10
228.182903372899562901460.10
单位质量响应值RSD%判断
10331.1010296.170.24数据可信
供试品溶液-2024032821批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133505-335055.6729.1438.995.679.1439.01
273165-7316512.38612.39
363826-6382610.80510.80
470702-7070211.96911.97
522216-222163.7613.76
660674-6067410.27110.27
10min1189079-18907932.00831.3616.9232.0231.3816.94
2212263-21226335.93335.95
3178841-17884130.27530.29
4212513-21251335.97536.00
5127409-12740921.56921.57
6191534-19153432.42432.44
15min1269218-26921845.57544.3110.6845.6444.3710.69
2286155-28615548.44248.52
3266295-26629545.08045.15
4254677-25467743.11343.19
5209951-20995135.54235.58
6284088-28408848.09248.16
20min1287508-28750848.67149.377.5848.8149.517.59
2311680-31168052.76352.92
3305148-30514851.65751.80
4277642-27764247.00147.15
5256285-25628543.38543.49
6311440-31144052.72252.87
30min1303965-30396551.45751.595.2351.6851.825.24
2318771-31877153.96354.21
3313547-31354753.07953.31
4282771-28277147.86948.10
5288774-28877448.88549.06
6320694-32069454.28954.53
45min1305895-30589551.78451.805.0852.0952.125.09
2319974-31997454.16754.51
3315217-31521753.36253.68
4283991-28399148.07648.39
5290651-29065149.20349.46
6320355-32035554.23154.56
60min1304619-30461951.56851.795.0751.9652.185.08
2320810-32081054.30954.74
3315421-31542153.39653.80
4285138-28513848.27048.66
5289725-28972549.04649.38
6319824-31982454.14254.56
极限1313544-31354453.07853.412.4153.5653.902.44
2323961-32396154.84255.36
3317807-31780753.80054.30
4305508-30550851.71852.19
5308847-30884752.28352.70
6323408-32340854.74855.26
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.072903602898552899632899012898742899910.08
228.182899762897532898640.06
单位质量响应值RSD%判断
10330.9910286.160.31数据可信
供试品溶液-2024032821批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146361-463617.85210.6131.827.8510.6031.83
281570-8157013.81513.82
387695-8769514.85314.85
446437-464377.8657.86
542632-426327.2217.22
671046-7104612.03312.03
10min1172872-17287229.27930.5813.4329.2930.5913.43
2212556-21255636.00036.02
3200504-20050433.95933.98
4164172-16417227.80627.82
5146629-14662924.83424.85
6186471-18647131.58231.60
15min1266376-26637645.11646.175.0645.1846.245.08
2294775-29477549.92650.01
3283523-28352348.02048.10
4263627-26362744.65044.71
5258160-25816043.72443.78
6269094-26909445.57645.65
20min1316374-31637453.58453.291.8553.7253.441.87
2322463-32246354.61554.78
3312608-31260852.94653.11
4309380-30938052.39952.53
5307592-30759252.09752.22
6319436-31943654.10354.25
30min1331170-33117056.09055.281.6656.3255.521.66
2332027-33202756.23556.49
3320774-32077454.32954.58
4326371-32637155.27755.50
5319121-31912154.04954.26
6328899-32889955.70555.94
45min1331443-33144356.13655.201.7156.4655.531.72
2330692-33069256.00956.36
3321812-32181254.50554.85
4324628-32462854.98255.30
5317540-31754053.78154.08
6329325-32932555.77756.11
60min1331794-33179456.19655.151.8556.6155.571.85
2328455-32845555.63056.07
3321057-32105754.37754.81
4325369-32536955.10755.51
5316306-31630653.57253.97
6330732-33073256.01656.44
极限1334333-33433356.62655.461.6457.1355.971.64
2329738-32973855.84756.38
3321737-32173754.49255.01
4325657-32565755.15655.65
5321453-32145354.44454.93
6331776-33177656.19356.71
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.072892012890202892322893322893812892330.05
228.182901292900682900980.02
单位质量响应值RSD%判断
10303.9910294.460.07数据可信
供试品溶液-2024032921批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156088-560889.50810.1538.059.5110.1538.05
286545-8654514.67114.67
323184-231843.9303.93
478076-7807613.23613.24
548142-481428.1618.16
667318-6731811.41211.41
10min1213280-21328036.15630.1213.4836.1730.1413.48
2174381-17438129.56129.59
3149162-14916225.28625.29
4198939-19893933.72533.75
5166512-16651228.22728.24
6163711-16371127.75327.77
15min1279122-27912247.31742.2410.7747.3942.3010.77
2227481-22748138.56338.64
3236869-23686940.15540.20
4283853-28385348.11948.20
5247959-24795942.03542.10
6219614-21961437.22937.29
20min1306698-30669851.99248.379.5052.1548.519.50
2249736-24973642.33642.47
3287038-28703848.65948.77
4313389-31338953.12653.28
5300440-30044050.93151.06
6254809-25480943.19643.32
30min1316989-31698953.73751.765.0953.9851.985.10
2297151-29715150.37450.58
3307785-30778552.17652.37
4318211-31821153.94454.19
5314068-31406853.24153.46
6277850-27785047.10247.30
45min1317063-31706353.74951.955.0054.0852.265.01
2299040-29904050.69450.99
3309594-30959452.48352.77
4321394-32139454.48354.82
5312246-31224652.93353.24
6279329-27932947.35247.63
60min1315448-31544853.47552.144.5253.9052.524.53
2302710-30271051.31651.69
3310009-31000952.55352.92
4320767-32076754.37754.80
5314286-31428653.27853.67
6282041-28204147.81248.17
极限1320826-32082654.38753.072.5654.9053.552.60
2306203-30620351.90852.37
3309947-30994752.54353.00
4321972-32197254.58155.10
5316909-31690953.72354.20
6302603-30260351.29851.73
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.072912132914792912832914022910742912900.06
228.182904822903762904290.03
单位质量响应值RSD%判断
10377.2710306.210.49数据可信
供试品溶液-2024032921批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192405-9240515.6008.9550.4515.608.9550.47
237022-370226.2506.25
340383-403836.8186.82
447888-478888.0858.08
522171-221713.7433.74
678109-7810913.18713.19
10min1230244-23024438.87130.1620.5338.9030.1820.54
2146353-14635324.70824.72
3178351-17835130.11030.12
4144779-14477924.44324.46
5156472-15647226.41726.42
6215791-21579136.43136.45
15min1279277-27927747.15044.515.5647.2444.575.58
2255925-25592543.20743.26
3267859-26785945.22245.28
4269236-26923645.45445.51
5237973-23797340.17640.23
6271443-27144345.82745.91
20min1300186-30018650.68051.926.3450.8552.066.31
2336910-33691056.88057.00
3304853-30485351.46751.60
4324359-32435954.76154.89
5285361-28536148.17748.29
6293501-29350149.55149.71
30min1307724-30772451.95253.543.7052.2153.773.67
2324633-32463354.80755.03
3320346-32034654.08354.31
4333609-33360956.32256.54
5315482-31548253.26253.46
6301079-30107950.83051.07
45min1308881-30888152.14753.243.4552.4953.563.41
2316118-31611853.36953.68
3322608-32260854.46554.78
4329562-32956255.63955.95
5316662-31666253.46153.75
6298286-29828650.35950.69
60min1303648-30364851.26453.473.9351.6953.873.89
2325444-32544454.94455.34
3322776-32277654.49354.90
4330333-33033355.76956.18
5318577-31857753.78454.16
6299371-29937150.54250.95
极限1313954-31395453.00454.101.9553.5254.591.92
2326778-32677855.16955.66
3319083-31908353.87054.36
4328601-32860155.47755.98
5320313-32031354.07854.54
6313875-31387552.99153.49
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